Implantable actuator for hearing aid application

ABSTRACT

An electromechanical actuator for an implantable hearing aid device including a mechanical output structure that has a first portion and a second portion, wherein the first portion is a mechanical attachment structure to attach a stapes prosthesis, and wherein the second portion is a wire-like member coupling the mechanical attachment structure to a magnetically permeable armature shaft assembly.

RELATED APPLICATIONS

The present application is related to U.S. Provisional PatentApplication No. 60/631,512 entitled “Implantable Fixation System forAnchorage of Medical Devices,” filed 30 Nov. 2004, which is herebyincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to treatments for hearing loss. In aparticular form, the present invention relates to an implantableactuator capable of direct stimulation of the middle and inner earauditory systems.

BACKGROUND OF THE INVENTION

Today state-of-the-art conventional hearing aids are able to treathearing loss, in particular sensorineural hearing loss, very efficientlybut still have some major disadvantages such as occlusion of theauditory canal, feedback at high amplification levels and stigmatizationof the patients with hearing loss. Further they are rather ineffectivein the treatment of conductive and mixed hearing loss. Whilst thepresent invention is described in relation to the treatment of hearingloss it will be appreciated that the invention will have otherapplications consistent with the principles described in thespecification.

It is an object of the present invention to provide a stimulation devicecapable of being included in an implantable hearing aid device thataddresses one or more of the disadvantages of conventional hearing aiddevices.

SUMMARY OF THE INVENTION

In a first aspect the present invention accordingly provides anelectromechanical actuator comprising:

-   -   first and second magnets arranged to provide a biasing field in        a field region between two substantially opposed pole faces of        said first and second magnets;    -   a magnetically permeable armature located in said biased field        region between said opposed pole faces, the location of the        magnetically permeable armature defining a first and second        working gap between the magnetically permeable armature and        respective opposed pole faces of the first and second magnets;    -   a magnetically permeable armature shaft assembly supporting said        magnetically permeable armature, said magnetically permeable        armature shaft assembly arranged to allow movement of said        magnetically permeable armature between said opposed pole faces        in a longitudinal direction defined by the movement of said        armature shaft assembly;    -   biasing means for providing a biasing force to said magnetically        permeable armature shaft assembly to bias said magnetically        permeable armature to a predetermined location between said        opposed pole faces; and    -   magnetic flux generating means responsive to an input signal to        generate a signal flux to modulate said biasing field in said        field region thereby providing an unbalanced force to said        magnetically permeable armature causing actuation of said        magnetically permeable armature shaft assembly.

Preferably, said first and second magnets are supported by a magnetsupport assembly and wherein said magnet support assembly, saidmagnetically permeable armature and said first and second working gapsform a first magnetic circuit.

Preferably, said magnetic flux generating means is supported by a fluxgenerating means support assembly and wherein said flux generating meanssupport assembly, said magnetically permeable armature, saidmagnetically permeable armature shaft assembly and one of said first andsecond working gaps forms a second magnetic circuit.

Preferably, said magnetic flux generating means comprises an electricalcoil.

Preferably, said flux generating means support assembly comprises amagnetically permeable structure having a recess to receive a shaft ofsaid magnetically permeable armature shaft assembly, thereby forming atransverse air gap between said shaft and the walls of said recess.

Preferably, said recess is substantially cylindrical in shape.

Preferably, said transverse air gap is minimized to reduce thereluctance of said second magnetic circuit.

Preferably, said biasing means includes a first biasing member and asecond biasing member.

Preferably, said flux generating means support assembly comprises saidfirst biasing member and wherein said first biasing member furthercomprises a magnetically permeable spring in mechanical contact with ashaft of said magnetically permeable armature shaft assembly.

Preferably, said second biasing member comprises a diaphragm inmechanical contact with said shaft.

In a second aspect the present invention accordingly provides anelectromechanical actuator for an implantable hearing aid devicecomprising:

-   -   a hermetic housing of tubular shape closed on one side with a        diaphragm and on the other side, with a hermetic feedthrough;    -   first and second magnets located in said hermetic housing        arranged to provide a biasing field in a field region between        two substantially opposed pole faces of said first and second        magnets;    -   a magnetically permeable armature located in said biased field        region between said opposed pole faces, the location of the        magnetically permeable armature defining a first and second        working gap between the magnetically permeable armature and        respective opposed pole faces of the first and second magnets;    -   a magnetically permeable armature shaft assembly supporting said        magnetically permeable armature, said magnetically permeable        armature shaft assembly arranged to allow movement of said        magnetically permeable armature between said opposed pole faces        in a longitudinal direction defined by the movement of said        magnetically permeable armature shaft assembly;    -   biasing means to provide a biasing force to said magnetically        permeable armature shaft assembly to bias said magnetically        permeable armature to a predetermined location between said        opposed pole faces;    -   magnetic flux generating means including an electrical signal        coil responsive to an input signal delivered by an electrical        connection to said hermetic feedthrough to generate a signal        flux to modulate the biasing field in said field region thereby        providing an unbalanced force to said magnetically permeable        armature causing actuation of said magnetically permeable        armature shaft assembly;    -   a mechanical output structure including stimulation means to        stimulate the inner ear auditory system responsive to actuation        of said magnetically permeable armature shaft assembly; and    -   a lead electrically connected to outer pins of said hermetic        feedthrough and mechanically attached to said titanium housing.

In a third aspect the present invention accordingly provides animplantable stimulation device for stimulating an inner ear of apatient, said stimulation device including an electromechanical actuatorresponsive to an auditory signal for providing mechanical stimulation tosaid inner ear in response to said auditory signal.

Preferably, said stimulation device further includes a middle earprosthetic, said middle ear prosthetic reproducing in part or in fullthe function of the middle ear, wherein said electromechanical actuatorincludes actuation means to actuate said middle ear prosthetic therebystimulating said inner ear in response to said auditory signal.

BRIEF DESCRIPTION OF THE DRAWINGS

A preferred embodiment of the present invention will be discussed withreference to the accompanying drawings wherein:

FIG. 1 is a perspective view of the interior components of animplantable hearing aid device incorporating an electromechanicalactuator in accordance with a first embodiment of the present invention;

FIG. 2 is a composite view of the implantable hearing aid deviceillustrated in FIG. 1;

FIG. 3 is an elevation view in longitudinal diametric section of theelectromechanical actuator illustrated in FIG. 1 having a low reluctancetransverse gap;

FIG. 4 is an elevation view in longitudinal diametric section of asecond embodiment of an electromechanical actuator of the presentinvention having a flux conducting spring member;

FIG. 5 is a lower elevation view in longitudinal diametric section ofthe electromechanical actuator illustrated in FIG. 1, showing theattachment of coil wires and lead;

FIG. 6 is an elevation view in longitudinal diametric section of theelectromechanical actuator illustrated in FIG. 1, showing the mechanicaloutput structure;

FIG. 7 is a side view of the mechanical output structure illustrated inthe above figures, with an attached stapes prosthesis;

FIG. 8 is a side view of the mechanical output structure illustrated inthe above figures, having a ball joint between coupling rod andartificial incus;

FIG. 9 is a side view of the mechanical output structure illustrated inthe above figures, having a bendable coupling rod;

FIG. 10 is a side view of the mechanical output structure illustrated inthe above figures, having a partially bendable coupling rod;

FIG. 11 is a side view of the mechanical output structure illustrated inthe above figures, having a ball joint between artificial incus andstapes prosthesis; and

FIG. 12 is a perspective view of a cochlear implant system showing oneexemplary application of the electromechanical actuator of the presentinvention.

In the following description, like reference characters designate likeor corresponding parts throughout the several views of the drawings.

DESCRIPTION OF PREFERRED EMBODIMENT

Referring now to FIGS. 1 and 2, there are shown perspective andcomposite views depicting the components of an implantable hearing aiddevice 100 incorporating an electromechanical actuator 50 according to afirst embodiment of the present invention. Hearing aid device 100includes a housing 1 formed from titanium tubing that is substantiallycylindrical and of circular cross section. Hearing aid device 100further comprises a titanium diaphragm 6, a titanium ring 21 and amulti-pin feedthrough 9 which are joined by hermetic laser welds.Coupling rod 7, which is part of the moving mechanical output structureof electromechanical actuator 50, is placed in ring 21 and ishermetically welded to it. This assembly provides a hermetically closedhousing 1 that is suitable for implantation in the human body.

Lead 11 which provides the input signal to electromechanical actuator 50is connected to feedthrough 9. To protect the connection site of thelead 11, electromechanical actuator 50 may be covered by a siliconefilled titanium cap 10. In this embodiment directed to a hearing aiddevice, the titanium cap 10 provides multiple flat surface regions toallow secure manipulation of the device during implantation withsurgical tweezers or little tongs. The titanium cap 10 also has aconical shape that provides mechanical transition between the smalldiameter of the lead 11 and larger diameter of the titanium tube 1.

Referring now to FIG. 3, there is shown an elevation view inlongitudinal diametric section of the first embodiment ofelectromechanical actuator 50 of the present invention incorporating alow reluctance transverse gap. Armature 2, shaft 12 and coupling rod 7form the moving part of the actuator 50. As armature 2 and shaft 12 formpart of the magnetic circuits which drive electromechanical actuator 50they are made of soft magnetic alloys. However, as would be understoodby those skilled in the art, other suitable materials having the desiredmagnetic permeability properties may also be used.

Shaft 12 is made of titanium to enable hermetic closing of the actuatorby welding it to a ring 21. The resulting moving structure iselastically supported at one side by a diaphragm 6, which performs thefunction of a restoring spring. As such, diaphragm 6 prevents magneticsnap over. On the other side, shaft 12 is supported in the longitudinaldirection by a spring bearing 5 having a spring constant sufficient toprovoke, together with diaphragm 6, the demanded dynamic characteristicof this spring-mass structure.

The armature 2 is centred between two permanent magnets 3 a and 3 bthereby forming two working gaps 17 a and 17 b. Both magnets 3 a and 3 bare polarized in the same direction substantially in parallel to theactuator axis and the direction of movement of shaft 12, and providepolarizing flux in working gaps 17 a and 17 b that extends through thearmature 2. This first magnetic circuit is closed through the magnetsupports 16 a and 16 b and the short sleeve 15 which are againfabricated from soft magnetic alloys.

A second magnetic circuit comprises signal coil 4, coil core 13, longsleeve 14, the magnet support 16 b, the armature 2 and the shaft 12.Signal coil 4 includes two input coil wires 23 which are connected tolead 11 by virtue of feedthrough 9. Preferably, all elements forming thesecond magnetic circuit other than the signal coil 4 are made of softmagnetic alloys to conduct the signal flux generated by coil 4. Thismagnetic signal circuit includes two air gaps: the working gap 17 b anda transverse gap 18 formed between the coil core 13 and the shaft 12.The transverse gap 18 between the coil core 13 and shaft 12 has beenminimized in order to provide a low reluctance thereby minimize lossesin the magnetic circuit.

In operation, the signal flux passing through the working gap 17 b hasthe effect of modulating the polarizing flux generated by the magnets 3a and 3 b in the process either increasing or decreasing the flux in theworking gap 17 b depending on the direction of the current passingthrough the signal coil 4. This in turn increases or decreases theattractive force in gap 17 b compared to the constant polarizing flux ingap 17 a which results in a net force pulling the armature upwards ordownwards. In this manner, small changes in the signal flux generated bycoil 4 will result in corresponding actuation of shaft 12 therebyproviding an electromechanical actuator of enhanced sensitivity.

Referring now to FIG. 4, there is shown an elevation view inlongitudinal diametric section of a second embodiment of anelectromechanical actuator 55. The main structure of theelectromechanical actuator 55 is the same as shown in FIG. 3, however,the spring bearing 5 and the transverse gap 18 of the FIG. 3 embodimentare replaced by flux conducting spring members 25 in this secondembodiment. Flux conducting spring members 25 are preferably made ofsoft magnetic alloys providing reduced reluctance to overcome the lossesresulting from the increased air gap 18 when compared to the air gapbetween the shaft 12 and coil core 13 in the first embodiment.

The use of multiple spring members 25 separated by flux conductingspacers 26 increases the sectional area that can be passed by themagnetic flux to further reduce the overall reluctance of the magneticcircuit. Compared to one spring that is simply increased in thickness,the multiple springs provide higher compliance.

Referring now to FIG. 5, there is shown an elevation view inlongitudinal diametric section of the first embodiment of theelectromechanical actuator 55 showing the attachment of the coil wires23 and lead 11. Coil wires 23 are attached to feedthrough pins 24 by,for example, brazing, welding or gluing with an electrically conductiveglue. To prevent coil wires 23 from coming into contact with movingshaft 12 or spring bearing 5, a cover 20 is placed between the coilwires and the shaft.

The terminals 27 of lead 11 are inserted in a crimping tube 31 that iswelded to the feedthrough pin 24. Crimping the tube 31 mechanicallyattaches lead terminal 27 and establishes a low-impedance electricalconnection. In this embodiment, a cap 10 protects the whole connectionsite. The cavity 32 formed by the cap 10 is filled up with silicone toprovide a firm mechanical attachment of the lead 11. To enable propersterilization of the silicone, the cap 10 provides multiple openings 28.

Referring now to FIG. 6, there is shown an elevation view inlongitudinal diametric section of the moving mechanical output structure110 forming part of the implantable hearing aid device 100 illustratedin FIGS. 1 and 2. Mechanical output structure 110 comprises a couplingrod 7 and an artificial incus 8, both made of titanium and, in thisembodiment, welded together. A silicone coating 38 covers artificialincus 8. The artificial incus 8 closely emulates the long process of theincus of the human middle ear, and is placed next to it duringimplantation.

The length of the coupling rod 7, measured from the outer surface of thediaphragm 6 to the end of the coupling rod 7, is chosen in the rangefrom approximately 3 mm to approximately 20 mm, and preferably in therange from approximately 5 mm to approximately 8 mm, to place theartificial incus 8 in the intended location. The angle formed by theaxis of the coupling rod 7 and the axis of the artificial incus 8 ischosen in the range from 80° to 150°, preferably in the range from 115°to 125°, in order to correctly orientate the artificial incus 8according to the anatomical conditions in the human middle ear.

The cross sectional profile of the artificial incus 8 is elliptical witha numeric eccentricity in the range from 0 to 0.5 in order to providereliable mechanical connection of the stapes prosthesis by crimping.Additionally, the artificial incus 8 is covered with a silicone coating38 that has a thickness chosen in the range from 0.05 mm to 0.2 mm inorder to allow proper stapes prosthesis attachment and crimping. Itshould be appreciated that the above dimensions and distances areapproximate and that other dimensions may be established in alternativeembodiments.

Referring now to FIG. 7, there is shown a schematic diagram of oneembodiment of the mechanical output structure of FIG. 6 with an attachedstapes prosthesis 33.

Referring now to FIG. 8, there is shown another embodiment of themechanical output structure having a ball joint 35 between coupling rod39 and artificial incus 40 to allow intra-operative adjustment of theangle between the coupling rod 39 and the artificial incus 40.

Referring now to FIG. 9, there is shown yet another embodiment of themechanical output structure having a bendable coupling rod 41 to allowintra-operative adjustment of the orientation and the location of theartificial incus 8. FIG. 10 shows yet another embodiment of themechanical output structure having a two part coupling rod, a stiff part42 next to actuator 50, 55 and a bendable part 36 next to the artificialincus 8 to allow intra-operative adjustment of the orientation and thelocation of the artificial incus 8.

Referring now to FIG. 11, there is shown a further embodiment of themechanical output structure having a stapes prosthesis 34 directlyattached to the artificial incus 43 via a ball joint 37 to allowintra-operative adjustment of the insertion angle of the stapesprosthesis 34.

Referring now to FIG. 12, there is shown implantable hearing aid device1200 implementing an electromechanical actuator 1210 according to apreferred embodiment of the present invention. In this preferredembodiment, implantable hearing aid device 1200 is a totally implantableCochlear™ prosthesis (also referred to as a Cochlear™ implant system,Cochlear™ prosthetic device and the like) which functions as animplantable stimulation device for stimulating the inner ear byemploying an electromechanical actuator responsive to an auditorysignal. As would be apparent to those skilled in the art, theelectromechanical actuator of the present invention can be utilized incurrent or future implantable medical devices. These implantable medicaldevices can be either partially or totally implanted in an individual,and such implantation may be temporary or permanent.

Hearing aid device 1200 comprises external component assembly 1242 whichis directly or indirectly attached to the body of the recipient, and aninternal component assembly 1244 which is temporarily or permanentlyimplanted in the recipient. External assembly 1242 typically comprisesaudio pickup devices 1220 for detecting sound, a speech processing unit1216, a power source (not shown), and an external transmitter unit 1206comprising an external coil 1208. Speech processing unit 1216 processesthe output of audio pickup devices 1220 that are positioned by the ear1222 of the recipient. Speech processing unit 1216 generates codedsignals which are provided to external transmitter unit 1206 via cable1218.

Internal components 1244 comprise an internal receiver unit 1212, astimulator unit 1226, and a moving electromechanical actuator 1210according to a preferred embodiment of the present invention. Internalreceiver unit 1212, which comprises an internal transcutaneous transfercoil 1224, and stimulator unit 1226 are hermetically sealed within ahousing 1228. Collectively, transmitter antenna coil 1208 and receiverantenna coil 1224 form an inductively-coupled coil system used totransfer data and power via a radio frequency (RF) link 114. A cable1230 extends from stimulator unit 1226 to actuator 1210.

Actuator 1210 is coupled to the inner ear fluids via artificial incus 8extending through a cochleostomy. Signals generated by stimulator unit1226 are applied by mechanical actuator 1210 to inner ear fluids. Itshould be appreciated that the arrangement shown in FIG. 12 is aschematic representation only, and that embodiments of theelectromechanical actuator 1210 of the present invention may bepositioned in a variety of locations to provide the desired stimulativeeffect. For example, in the embodiment shown in FIG. 12, actuator 1210is coupled to the inner ear fluids via artificial incus 8. However, avariety of stapes prostheses may be attached to artificial incus 8 inalternative embodiments, as described above.

It should also be appreciated that electromechanical actuator 1210 maybe secured to the recipient utilizing a variety of techniques now orlater developed. In one embodiment, electromechanical actuator 1210 isconfigured to be implanted in a recipient utilizing an embodiment of afixation system described in commonly owned U.S. Provisional PatentApplication No. 60/631,512 entitled “Implantable Fixation System forAnchorage of Medical Devices,” filed 30 Nov. 2004, which is herebyincorporated by reference herein in its entirety.

A brief consideration of the above described embodiments will indicatethat the invention may be employed to remedy any source of conductivehearing loss. Additionally, these embodiments of the electromechanicalactuator may be configured to provide sufficiently high output levels totreat severe sensorineural hearing loss while being sufficiently smallto completely fit into a human mastoid.

It should also be appreciated that Cochlear™ implant system 1200described above is just one exemplary system in which theelectromechanical actuator of the present invention may be implemented.The electromechanical actuator of the present invention may beimplemented in a myriad of embodiments of a cochlear implant system,hearing aid or other medical devices or systems now or later developed.

Advantageously, the dimensions and shape of embodiments of theelectromechanical actuator of the present invention may be selected totake into account the anatomy of the implantation site. For example, foran actuator that is to be placed in a hole drilled into the humanmastoid, an elongated cylindrical shape such as that described above hasbeen found to be advantageous. In addition, in the above or otherapplication, embodiments of the actuator may have a diameter and alength which are sufficiently small to allow placement of the actuatorin narrow anatomical locations as required. A further advantage ofembodiments of the present invention directed to hearing aid devices isthat they are able to deliver sufficiently high output levels to manageprogressive hearing loss in order to prevent revision surgeries. A stillfurther advantage is that certain embodiments of the actuator are highlyenergy efficient thereby minimizing power consumption and facilitatingautonomy.

Although a preferred embodiment of the method and system of the presentinvention has been described in the foregoing detailed description, itwill be understood that the invention is not limited to the embodimentdisclosed, but is capable of numerous rearrangements, modifications andsubstitutions without departing from the scope of the invention as setforth and defined by the following claims.

It will be understood that the term “comprise” and any of itsderivatives (eg. comprises, comprising) as used in this specification isto be taken to be inclusive of features to which it refers, and is notmeant to exclude the presence of any additional features unlessotherwise stated or implied.

1.-33. (canceled)
 34. An electromechanical actuator for an implantable hearing aid device comprising: a hermetic housing of tubular shape closed on one side with a diaphragm and on the other side, with a hermetic feedthrough; first and second magnets located in said hermetic housing arranged to provide a biasing field in a field region between two substantially opposed pole faces of said first and second magnets; a magnetically permeable armature located in said biased field region between said opposed pole faces, the location of the magnetically permeable armature defining a first and second working gap between the magnetically permeable armature and respective opposed pole faces of the first and second magnets; a magnetically permeable armature shaft assembly supporting said magnetically permeable armature, said magnetically permeable armature shaft assembly arranged to allow movement of said magnetically permeable armature between said opposed pole faces in a longitudinal direction defined by the movement of said magnetically permeable armature shaft assembly; biasing means to provide a biasing force to said magnetically permeable armature shaft assembly to bias said magnetically permeable armature to a predetermined location between said opposed pole faces; magnetic flux generating means including an electrical signal coil responsive to an input signal delivered by an electrical connection to said hermetic feedthrough to generate a signal flux to modulate the biasing field in said field region thereby providing an unbalanced force to said magnetically permeable armature causing actuation of said magnetically permeable armature shaft assembly; a mechanical output structure including stimulation means to stimulate the inner ear auditory system responsive to actuation of said magnetically permeable armature shaft assembly; and a lead electrically connected to outer pins of said hermetic feedthrough and mechanically attached to said titanium housing, wherein said mechanical output structure has a first portion and a second portion, and wherein the first portion is a mechanical attachment structure to attach a stapes prosthesis, and wherein said second portion is a wire-like member coupling said mechanical attachment structure to said magnetically permeable armature shaft assembly.
 35. An electromechanical actuator for an implantable hearing aid device as claimed in claim 34, wherein said mechanical attachment structure is of substantially cylindrical shape with an elliptical cross section having a numeric eccentricity ranging from approximately 0 to approximately 0.5.
 36. An electromechanical actuator for an implantable hearing aid device as claimed in claim 34, wherein said mechanical attachment structure is covered with a silicone layer having a thickness of approximately 0.05 mm to approximately 0.2 mm
 37. An electromechanical actuator for an implantable hearing aid device as claimed in claim 34, wherein said wire-like member is a straight rod, and further wherein an angle between said mechanical attachment structure and said straight rod is chosen in the range of approximately 80° to approximately 150°.
 38. An electromechanical actuator for an implantable hearing aid device as claimed in claim 37, wherein said angle between said mechanical attachment structure and said straight rod is in the range from approximately 115° to approximately 125°.
 39. An electromechanical actuator for an implantable hearing aid device as claimed in claim 37, wherein ball joint means is disposed between said mechanical attachment structure and said straight rod to allow reorientation of said mechanical attachment structure with respect to said straight rod.
 40. An electromechanical actuator for an implantable hearing aid device as claimed in claim 34, wherein said wire-like member is at least partially bendable during implantation of said implantable hearing aid device.
 41. An electromechanical actuator for an implantable hearing aid device as claimed in claim 34, wherein said mechanical attachment structure includes further ball joint means to engage with a stapes prosthesis provided with a ball-shaped head. 